WO2024024533A1 - Bone screw - Google Patents

Bone screw Download PDF

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Publication number
WO2024024533A1
WO2024024533A1 PCT/JP2023/025979 JP2023025979W WO2024024533A1 WO 2024024533 A1 WO2024024533 A1 WO 2024024533A1 JP 2023025979 W JP2023025979 W JP 2023025979W WO 2024024533 A1 WO2024024533 A1 WO 2024024533A1
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WO
WIPO (PCT)
Prior art keywords
bone screw
thread
reinforcing fibers
head
shaft
Prior art date
Application number
PCT/JP2023/025979
Other languages
French (fr)
Japanese (ja)
Inventor
康平 森田
洋輝 大橋
諭 谷
雄一 村山
健司 土田
泰浩 古田
Original Assignee
株式会社スパインテック
株式会社タカイコーポレーション
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 株式会社スパインテック, 株式会社タカイコーポレーション filed Critical 株式会社スパインテック
Publication of WO2024024533A1 publication Critical patent/WO2024024533A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16BDEVICES FOR FASTENING OR SECURING CONSTRUCTIONAL ELEMENTS OR MACHINE PARTS TOGETHER, e.g. NAILS, BOLTS, CIRCLIPS, CLAMPS, CLIPS OR WEDGES; JOINTS OR JOINTING
    • F16B23/00Specially shaped nuts or heads of bolts or screws for rotations by a tool
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16BDEVICES FOR FASTENING OR SECURING CONSTRUCTIONAL ELEMENTS OR MACHINE PARTS TOGETHER, e.g. NAILS, BOLTS, CIRCLIPS, CLAMPS, CLIPS OR WEDGES; JOINTS OR JOINTING
    • F16B35/00Screw-bolts; Stay-bolts; Screw-threaded studs; Screws; Set screws

Definitions

  • the present invention relates to bone screws that can be fixed to animal bones.
  • a bone screw made almost entirely of metal causes artifacts when taking medical images, and becomes an obstacle when performing surgery, etc. while checking the medical images.
  • PEEK registered trademark
  • the bone screw of the present invention is a bone screw containing reinforcing fibers, and includes a shaft portion, a tip portion located at the end of the shaft portion in the insertion direction, and a head portion located at the end of the shaft portion in the withdrawal direction. and a screw thread located spirally in the axial direction of the shaft part on the outer circumferential part of the shaft part, and the reinforcing fiber is arranged in the shaft part at a position extending in the axial direction of the shaft part. be done.
  • a bone screw with sufficient strength can be provided.
  • FIG. 4(a) is a diagram showing the head of the bone screw of this embodiment.
  • FIG. 4(b) is a sectional view taken along line BB of the bone screw of this embodiment. It is a perspective view of the bone screw of this embodiment. It is a perspective view of the bone screw of this embodiment.
  • FIG. 2 is a sectional view taken along line CC of the bone screw of the present embodiment.
  • FIG. 1 is a side view and a sectional view of the bone screw of this embodiment.
  • FIG. 2 is a cross-sectional view of the shaft portion and screw thread of the bone screw of this embodiment.
  • the bone screw 1 of this embodiment is a bone screw containing reinforcing fibers, and includes a shaft portion 2 and a tip portion 3 located at the end of the shaft portion 2 in the insertion direction. , a head 4 located at the end of the shaft portion 2 in the removal direction, and a screw thread 5 located spirally in the axial direction of the shaft portion 2 on the outer circumference of the shaft portion 2.
  • FIG. 1(b) is a cross-sectional view taken along line AA in FIG. 1(a). As shown in FIG. 1(b), the reinforcing fibers 100 are arranged in the shaft portion 2 at a position extending in the axial direction of the shaft portion 2.
  • FIG. 1(c) is an enlarged cross-sectional view of the thread 5 of FIG. 1(b). As shown in FIG. 1(c), the reinforcing fiber 100 is bent at the thread 5.
  • the reinforcing fibers 100 are arranged in the thread 5 at a position extending in the same direction as the helical direction of the thread 5.
  • the reinforcing fibers 100 are arranged at positions extending along the helical direction of the threads 5.
  • the reinforcing fiber 100 is spirally wound in the axial direction around at least one of the shaft portion 2 and the screw thread 5.
  • a mixed composition of the reinforcing fiber 100 for example, 1 mm carbon fiber
  • a resin for example, vinyl ester
  • the reinforcing fibers 100 are mixed with the resin so that the reinforcing fibers 100 are arranged in a predetermined direction.
  • the reinforcing fibers 100 are mixed with the resin so that the reinforcing fibers 100 are arranged in the axial direction of the bone screw 1.
  • the reinforcing fibers 100 are mixed with the resin so that the reinforcing fibers 100 are arranged at a position extending at a predetermined angle with respect to the axial direction of the bone screw 1.
  • the reinforcing fibers 100 are mixed into the resin so that they are arranged in the helical direction of the threads 5 of the bone screw 1.
  • the resin includes at least one of a thermosetting resin and a thermoplastic resin.
  • the resin may be selected from epoxy resins, phenolic resins, unsaturated polyester resins, and the like.
  • the reinforcing fibers 100 are stretched in the axial direction of the shaft part 2 in the shaft part 2.
  • the reinforcing fiber 100 may be bent at the thread 5 or may be arranged at a position extending in the same direction as the helical direction of the thread 5, or the reinforcing fiber 100 may be bent at the thread 5, or may be arranged at a position where it extends in the same direction as the helical direction of the thread 5. , and may be arranged in a position where it is wound spirally around the axial direction.
  • the reinforcing fibers 100 are appropriately arranged in a predetermined direction to strengthen at least one of compressive strength, tensile strength, shear strength, torsional strength, and hardness of the bone screw 1. Can be done.
  • the reinforcing fiber 100 is preferably at least one of carbon fiber, aramid fiber, and glass fiber, but is not limited to these.
  • FIG. 2 is a cross-sectional view of a bone screw 1 in which a mixed composition of reinforcing fibers 100 and a resin is injection molded into a mold for the bone screw 1.
  • the angle of the thread 5 is 60 degrees or more and 80 degrees or less.
  • the inventor injected a mixed composition of reinforcing fibers 100 and resin into a mold for the bone screw 1, and determined the angle of the thread 5 for appropriately molding the thread 5 of the bone screw 1. I found out. If the angle of the threads in the mold is too small, the mixed composition will not be sufficiently injected to the threads, and the threads 5 will not be properly molded. On the other hand, if the angle of the threaded portion of the mold is too large, the fixing strength of the bone screw 1 to the bone will be insufficient and it will easily come off from the bone.
  • the angles of the threads 5 are 120 degrees and 100 degrees, respectively. As shown in FIGS. 2(a) and 2(b), although the mixed composition is sufficiently injected to the threaded portion, the angle of the threaded portion is too large and easily detaches from the bone.
  • the angles of the threads 5 are 80 degrees and 60 degrees, respectively.
  • the mixed composition is sufficiently injected to the threaded portion, and the angle of the threaded portion is not too large and does not easily detach from the bone. Therefore, it is appropriate that the angle of the thread 5 is 60 degrees or more and 80 degrees or less.
  • the angle of the thread 5 is 60 degrees or more and 75 degrees or less. More preferably, the angle of the thread 5 is 65 degrees or more and 70 degrees or less.
  • FIG. 3 is a diagram showing that the angle of the thread 5 increases in the range of 60 degrees to 80 degrees as it goes toward the insertion direction of the bone screw 1.
  • the angles ⁇ 1 to ⁇ 3 of the screw threads 5 increase in the range of 60 degrees to 80 degrees as the direction of insertion of the bone screw 1 increases ( ⁇ 1 ⁇ 2 ⁇ 3).
  • the angle of the thread 5 increases in the range of 60 degrees or more and 75 degrees or less as it goes toward the insertion direction of the bone screw 1. More preferably, the angle of the thread 5 increases in the range of 65 degrees or more and 70 degrees or less as it goes toward the insertion direction of the bone screw 1.
  • the angle of the thread 5 may gradually increase within the above range or may increase intermittently as it goes in the insertion direction of the bone screw 1, or a part of the thread 5 may It may become larger within the above range as it goes in the insertion direction of the screw 1. Further, the heights h1 to h3 of the screw threads 5 may become lower toward the insertion direction of the bone screw 1. The heights h1 to h3 of the threads 5 may vary depending on the angle of the threads 5.
  • FIG. 4(a) is a diagram showing the head 4 of the bone screw 1.
  • FIG. 4(b) is a sectional view of the bone screw 1 taken along line BB.
  • the head 4 includes a head protrusion 41 in the insertion direction, and the head protrusion 41 fits into the shaft recess 21 of the shaft portion 2.
  • the joint between the head 4 and the shaft portion 2 (the convex head portion 41) has higher at least one of compressive strength, tensile strength, shear strength, torsional strength, and hardness than the shaft portion 2.
  • the head convex portion 41 is made of at least metal (e.g., titanium, stainless steel, iron, nickel, cobalt, cemented carbide, etc.), ceramic (e.g., zirconia), cermet, and reinforcing fibers having a composition different from that of the reinforcing fibers 100.
  • the reinforcing fibers having a different composition from the reinforcing fibers 100 may be reinforcing fibers of the same type as the reinforcing fibers 100, as long as at least one of the mixing ratio, length, shape, and arrangement of the reinforcing fibers 100 is different.
  • the reinforcing fibers having a different composition from the reinforcing fibers 100 may be reinforcing fibers of the same type as the reinforcing fibers 100 if other reinforcing fibers are mixed therein.
  • the joint between the head 4 and the shaft portion 2 has higher compressive strength, tensile strength, shear strength, torsional strength, and hardness than the shaft portion 2. It is sufficient that at least one of them is high.
  • the shaft portion 2 may include a shaft protrusion in the removal direction, and the shaft protrusion may fit into a head recess of the head 4. That is, in FIG. 4, the head 4 is provided with a convex portion and the shaft portion 2 is provided with a concave portion, but conversely, the shaft portion 2 may be provided with a convex portion and the head 4 may be provided with a concave portion.
  • the core part may be fitted into a head recess of the head 4 and a shaft recess of the shaft part 2. That is, the head 4 and the shaft portion 2 are provided with recesses, and the recesses are connected by the core.
  • a portion having at least one of compressive strength, tensile strength, shear strength, torsional strength, and hardness higher than that of the shaft portion 2 may be provided at the joint portion between the head portion 4 and the shaft portion 2.
  • the joint may be a boundary between the head 4 and the shaft 2 made of different materials, as shown in FIG. There does not have to be any boundary surface.
  • the compressive strength is higher than that of the shaft part 2.
  • a portion having high at least one of tensile strength, shear strength, torsional strength, and hardness may be provided between the head 4 and the shaft portion 2.
  • At least one of compressive strength, tensile strength, shear strength, torsional strength, and hardness can be strengthened in the part between the head 4 and the shaft part 2 where the load is applied, and the bone screw 1 can be broken. and deformation can be prevented.
  • FIG. 5 is a perspective view of the bone screw 1.
  • FIG. 6 is a perspective view of the bone screw 1 of FIG. 5.
  • FIG. 7 is a sectional view taken along line CC of the bone screw 1 in FIG.
  • the head 4 includes a head protrusion 41 in the insertion direction, and the head protrusion 41 fits into the shaft recess 21 of the shaft portion 2.
  • the head convex portion 41 includes a polygonal portion 41-1 whose cross section perpendicular to the axial direction is a polygon.
  • the polygonal portion 41-1 has a substantially rectangular cross section perpendicular to the axial direction, and is chamfered.
  • the polygonal portion 41-1 is preferably approximately triangular to approximately hexagonal. Since the head protrusion 41 has a polygonal cross-section perpendicular to the axial direction, when torque is generated in the rotational direction of the bone screw 1, the head protrusion 41 slides or comes off from the shaft recess 21 in the rotational direction. This can be prevented.
  • the head protrusion 41 includes a notch 22.
  • the cutout portion 22 may include a rotation surface in the rotational direction of the bone screw 1, or may have a flange shape.
  • the head protrusion 41 may include a screw thread located in a reverse helical direction to the screw thread 5.
  • the shaft recess 21 may include at least one of a polygonal section whose cross section perpendicular to the axial direction is a polygon, a thread located in a reverse helical direction with respect to the thread 5, and a notch.
  • the convex part of the shaft part 2 when the convex part of the shaft part 2 fits into the recessed part of the head part 4, or when the core part fits into the head recessed part of the head part 4 and the shaft recessed part of the shaft part 2,
  • the convex part of the shaft part 2, the concave part of the head part 4, and the core part have a polygonal part whose cross section perpendicular to the axial direction is a polygon, or a thread located in a reverse spiral direction with respect to the thread 5, and a notch part. At least one may be provided.
  • the core portion may include reinforcing fibers arranged at at least one of a position extending in the axial direction and a position spirally wound around the axial direction.
  • the bone screw 1 includes a hole 20 that can pass through the inside of the bone screw 1 in the axial direction. 6 and 7, the hole 20 passes through the interior of the bone screw 1 from the recess 40 of the head 4 to the distal end 3.
  • the hole 20 passes through the interior of the bone screw 1 from the recess 40 of the head 4 to the distal end 3.
  • the hole 20 is made of at least one of metal (e.g., titanium, stainless steel, iron, nickel, cobalt, cemented carbide, etc.), ceramic (e.g., zirconia), cermet, and reinforcing fiber having a composition different from that of the reinforcing fiber 100.
  • metal e.g., titanium, stainless steel, iron, nickel, cobalt, cemented carbide, etc.
  • ceramic e.g., zirconia
  • cermet e.g., cermet
  • reinforcing fiber having a different composition from the reinforcing fibers 100 may be reinforcing fibers of the same type as the reinforcing fibers 100, as long as at least one of the mixing ratio, length, shape, and arrangement of the reinforcing fibers 100 is different.
  • the reinforcing fibers having a different composition from the reinforcing fibers 100 may be reinforcing fibers of the same type as the reinforcing fibers 100 if other reinforc
  • Hole 20 surrounded by a material including metal (e.g., titanium, stainless steel, iron, nickel, cobalt, and cemented carbide), ceramic (e.g., zirconia), cermet, and reinforcing fibers having a composition different from reinforcing fiber 100
  • metal e.g., titanium, stainless steel, iron, nickel, cobalt, and cemented carbide
  • ceramic e.g., zirconia
  • cermet e.g., cermet
  • reinforcing fibers having a composition different from reinforcing fiber 100
  • the hole 20 is made of metal (e.g., titanium, stainless steel, iron, nickel, cobalt, cemented carbide, etc.), ceramic (e.g., zirconia), cermet, or reinforced fiber having a composition different from that of the reinforcing fiber 100. It suffices if it is surrounded by a material containing at least one fiber.
  • metal e.g., titanium, stainless steel, iron, nickel, cobalt, cemented carbide, etc.
  • ceramic e.g., zirconia
  • cermet e.g., zirconia
  • reinforced fiber having a composition different from that of the reinforcing fiber 100. It suffices if it is surrounded by a material containing at least one fiber.
  • FIG. 8 is a diagram showing examples of the types of threads 5 of the bone screw 1.
  • the flank angle of the thread 5 in the insertion direction is larger than the flank angle of the thread 5 in the removal direction.
  • the shaft portion 2 becomes thinner toward the insertion direction, and the diameter of the valley of the thread 5 becomes thinner and smaller toward the insertion direction.
  • the outer diameter of the thread 5 is substantially constant.
  • the height of the thread 5 increases toward the insertion direction.
  • the length of the top of the screw thread 5 in the axial direction becomes smaller toward the insertion direction.
  • the bone screw 1 Due to the shape of the screw thread 5, the bone screw 1 can be reliably fixed to the bone and can be easily removed from the bone.
  • FIG. 9 is a diagram showing another example of the type of thread 5 of the bone screw 1.
  • FIG. 9 is a cross-sectional view of the thread 5 of the bone screw 1.
  • the flank angle ⁇ of the thread 5 in the insertion direction is larger than the flank angle ⁇ of the thread 5 in the removal direction.
  • the heights H1, H2, and H3 of the screw threads 5 increase toward the insertion direction.
  • the bone screw 1 shown in FIG. 9 the bone screw 1 shown in FIG.
  • the axial lengths L1, L2, and L3 of the tops of the screw threads 5 are in the insertion direction. The smaller it becomes.
  • the diameter of the valley of the thread 5 and the angle ⁇ of the thread 5 are substantially constant.
  • the shaft portion 2 becomes thinner toward the insertion direction, and the diameter of the valley of the screw threads 5 (thread threads 5-4, 5-5, 5-6) is in the insertion direction. It becomes thinner and smaller as it goes towards the end.
  • the outer diameter of the thread 5 and the angle ⁇ of the thread 5 are substantially constant.
  • the heights H4, H5, and H6 of the threads 5 increase toward the insertion direction.
  • the axial lengths L4, L5, and L6 of the tops of the screw threads 5 are in the insertion direction. The smaller it becomes.
  • the bone screw 1 Due to the shape of the screw thread 5, the bone screw 1 can be reliably fixed to the bone and can be easily removed from the bone.
  • FIG. 10 is a diagram showing that the bone screw 1 housed in the housing 6 is fixed within the housing 6 by a nut (not shown) and connected by a rod 7.
  • the threads 5-7 of the bone screw 1 have the same shape as the threads 5 in FIG. 8(b). As shown in FIG. 10(b), the pitch of the threads 5 of the bone screw 1 becomes longer toward the insertion direction.
  • the bone screw 1 Due to the shape of the screw thread 5, the bone screw 1 can be reliably fixed to the bone and can be easily removed from the bone.
  • FIG. 11 is a CT image (medical image) taken with the bone screw 1 screwed into the bone of an animal (pig).
  • the bone screw 1 contains tantalum of 0 weight % or more and 30 weight % or less (0 weight %, 10 weight %, 15 weight %, 20 weight %, 25 weight %, 30 weight %) and reinforcing fibers. including mixtures mixed into compositions.
  • FIG. 12 is a table evaluating artifacts of the bone screw 1 in CT images (medical images) taken according to the tantalum content shown in FIG. 11.
  • the artifact rating is A - , which is acceptable. Similar results are expected for other metals (titanium, stainless steel, iron, nickel, cobalt, cemented carbide, etc.).
  • the bone screw 1 (at least one of the shaft portion 2, the tip portion 3, the head 4, and the screw thread 5) contains more than 0% by weight and less than 30% by weight (preferably 10% by weight and less than 20% by weight), More preferably, the reinforcing fiber 100 contains a mixture of a metal (tantalum, titanium, stainless steel, iron, nickel, cobalt, cemented carbide, etc.) containing 10% by weight or more and 15% by weight or less, such as tantalum, titanium, stainless steel, iron, nickel, cobalt, and cemented carbide.
  • a metal tantalum, titanium, stainless steel, iron, nickel, cobalt, and cemented carbide.
  • the bone screw 1 (at least one of the shaft portion 2, the tip portion 3, the head 4, and the screw thread 5) is imaged with higher brightness than the surrounding area in a medical image while reducing artifacts
  • the bone screw 1 ( At least one of the shaft portion 2, the tip portion 3, the head portion 4, and the screw thread 5) functions as a guide for grasping the position and direction of the bone screw 1 in a medical image.
  • the tip portion 3 may include a material that is imaged with higher brightness in medical images than the reinforcing fiber 100.
  • the tip portion 3 may be made of metal (e.g., tantalum, titanium, stainless steel, iron, nickel, cobalt, cemented carbide, etc.), ceramic (e.g., zirconia), cermet, or reinforcing fiber having a composition different from that of the reinforcing fiber 100. Contains at least one. When such a distal end 3 is imaged with higher brightness than the surrounding area of the distal end 3 in a medical image such as a CT image, the distal end 3 is used for grasping the position and direction of the bone screw 1 in the medical image. Act as a guide.
  • the present invention is useful as a bone screw with sufficient strength.

Abstract

In order to provide a bone screw having adequate strength, a bone screw (1) includes reinforcing fibers (100) and comprises a shaft portion (2), a tip end portion (3) located at an end of the shaft portion in an insertion direction, a head portion (4) located at an end of the shaft portion in a removal direction, and a screw thread (5) located with a helical shape in an axial direction of the shaft portion on an outer circumferential portion of the shaft portion, wherein the reinforcing fibers are configured to be disposed in the shaft portion in locations extending in the axial direction of the shaft portion.

Description

骨螺子bone screw
 本発明は、動物の骨に固定可能な骨螺子に関する。 The present invention relates to bone screws that can be fixed to animal bones.
 脳神経外科等の分野の手術において動物(特に、人間)の骨を固定するために、骨に突刺する先端部を含む骨螺子が開発されている(特許文献1参照)。 In order to fix the bones of animals (particularly humans) in surgeries in fields such as neurosurgery, bone screws have been developed that include a tip that pierces the bones (see Patent Document 1).
 従来は、骨を固定する強度を保つために、略全体が金属製(ステンレス等)やPEEK(登録商標)の骨螺子が提案されている。 Conventionally, bone screws made almost entirely of metal (such as stainless steel) or PEEK (registered trademark) have been proposed in order to maintain the strength of fixing bones.
特許第5443398号公報Patent No. 5443398
 しかしながら、略全体が金属製(ステンレス等)の骨螺子は、医用画像を撮像する際にアーチファクトの原因となり、医用画像を確認しながら手術等を行うときの妨げとなる。また、PEEK(登録商標)は、強度が十分でない場合がある。 However, a bone screw made almost entirely of metal (stainless steel, etc.) causes artifacts when taking medical images, and becomes an obstacle when performing surgery, etc. while checking the medical images. Furthermore, PEEK (registered trademark) may not have sufficient strength.
 本発明の骨螺子は、強化繊維を含む骨螺子であって、シャフト部と、前記シャフト部の挿入方向の端部に位置する先端部と、前記シャフト部の抜去方向の端部に位置する頭部と、前記シャフト部の外周部において前記シャフト部の軸方向に螺旋状に位置するネジ山とを備え、前記強化繊維は、前記シャフト部において、前記シャフト部の軸方向に延伸する位置に配置される。 The bone screw of the present invention is a bone screw containing reinforcing fibers, and includes a shaft portion, a tip portion located at the end of the shaft portion in the insertion direction, and a head portion located at the end of the shaft portion in the withdrawal direction. and a screw thread located spirally in the axial direction of the shaft part on the outer circumferential part of the shaft part, and the reinforcing fiber is arranged in the shaft part at a position extending in the axial direction of the shaft part. be done.
 本発明によれば、十分な強度を備える骨螺子を提供することができる。 According to the present invention, a bone screw with sufficient strength can be provided.
本実施形態の骨螺子の側面図と断面図である。They are a side view and a sectional view of the bone screw of this embodiment. 本実施形態の骨螺子のシャフト部及びネジ山の断面図である。It is a sectional view of a shaft part of a bone screw of this embodiment, and a screw thread. 本実施形態のネジ山の角度が、骨螺子の挿入方向に向かうほど、60度乃至80度の範囲内で大きくなることを示す図である。It is a figure which shows that the angle of the thread of this embodiment becomes large within the range of 60 thru|or 80 degrees, so that it goes to the insertion direction of a bone screw. 図4(a)は、本実施形態の骨螺子の頭部を示す図である。図4(b)は、本実施形態の骨螺子のB-Bの断面図である。FIG. 4(a) is a diagram showing the head of the bone screw of this embodiment. FIG. 4(b) is a sectional view taken along line BB of the bone screw of this embodiment. 本実施形態の骨螺子の斜視図である。It is a perspective view of the bone screw of this embodiment. 本実施形態の骨螺子の透視図である。It is a perspective view of the bone screw of this embodiment. 本実施形態の骨螺子のC-Cの断面図である。FIG. 2 is a sectional view taken along line CC of the bone screw of the present embodiment. 本実施形態の骨螺子のネジ山のタイプの例を示す図である。It is a figure which shows the example of the thread type of the bone screw of this embodiment. 本実施形態の骨螺子のネジ山のタイプの他の例を示す図である。It is a figure which shows the other example of the thread type of the bone screw of this embodiment. ハウジングに収納された本実施形態の骨螺子が、ハウジング内でナットにより固定され、ロッドにより連結されたこと示す図である。It is a figure which shows that the bone screw of this embodiment accommodated in the housing is fixed by the nut in the housing, and is connected by the rod. 動物の骨に骨螺子1を螺入した状態で撮像したCT画像(医用画像)である。This is a CT image (medical image) taken with a bone screw 1 screwed into an animal bone. タンタルの含有率に応じて撮像した医用画像における骨螺子のアーチファクトを評価した表である。2 is a table that evaluates bone screw artifacts in medical images taken according to tantalum content.
 本実施形態の骨螺子について、図面を用いて説明する。図1は、本実施形態の骨螺子の側面図と断面図である。図2は、本実施形態の骨螺子のシャフト部及びネジ山の断面図である。 The bone screw of this embodiment will be explained using the drawings. FIG. 1 is a side view and a sectional view of the bone screw of this embodiment. FIG. 2 is a cross-sectional view of the shaft portion and screw thread of the bone screw of this embodiment.
 図1(a)に示すように、本実施形態の骨螺子1は、強化繊維を含む骨螺子であって、シャフト部2と、シャフト部2の挿入方向の端部に位置する先端部3と、シャフト部2の抜去方向の端部に位置する頭部4と、シャフト部2の外周部においてシャフト部2の軸方向に螺旋状に位置するネジ山5とを備える。 As shown in FIG. 1(a), the bone screw 1 of this embodiment is a bone screw containing reinforcing fibers, and includes a shaft portion 2 and a tip portion 3 located at the end of the shaft portion 2 in the insertion direction. , a head 4 located at the end of the shaft portion 2 in the removal direction, and a screw thread 5 located spirally in the axial direction of the shaft portion 2 on the outer circumference of the shaft portion 2.
 図1(b)は、図1(a)のA-Aの断面図である。図1(b)に示すように、強化繊維100が、シャフト部2において、シャフト部2の軸方向に延伸する位置に配置される。図1(c)は、図1(b)のネジ山5の断面を拡大した図である。図1(c)に示すように、強化繊維100は、ネジ山5において屈曲する。 FIG. 1(b) is a cross-sectional view taken along line AA in FIG. 1(a). As shown in FIG. 1(b), the reinforcing fibers 100 are arranged in the shaft portion 2 at a position extending in the axial direction of the shaft portion 2. FIG. 1(c) is an enlarged cross-sectional view of the thread 5 of FIG. 1(b). As shown in FIG. 1(c), the reinforcing fiber 100 is bent at the thread 5.
 また、図示しないが、強化繊維100は、ネジ山5において、ネジ山5の螺旋方向と同じ方向に延伸する位置に配置される。強化繊維100は、ネジ山5の螺旋方向に沿って延伸する位置に配置される。 Further, although not shown, the reinforcing fibers 100 are arranged in the thread 5 at a position extending in the same direction as the helical direction of the thread 5. The reinforcing fibers 100 are arranged at positions extending along the helical direction of the threads 5.
 また、図示しないが、強化繊維100は、シャフト部2及びネジ山5の少なくとも1つにおいて、軸方向の周りを螺旋状に巻回する。 Further, although not shown, the reinforcing fiber 100 is spirally wound in the axial direction around at least one of the shaft portion 2 and the screw thread 5.
 強化繊維100を用いて骨螺子を射出成型する場合、強化繊維100(例えば、1mmの炭素繊維)と樹脂(例えば、ビニルエステル)を混合した混合組成物を、骨螺子1の金型に、骨螺子1の頭部側から骨螺子1の挿入方向へ射出する。この場合、混合組成物を組成する際に、強化繊維100が所定の方向に配置されるように、強化繊維100を樹脂に混合する。例えば、強化繊維100が骨螺子1の軸方向に配置されるように、強化繊維100を樹脂に混合する。あるいは、強化繊維100が骨螺子1の軸方向と所定の角度で延伸する位置に配置されるように、強化繊維100を樹脂に混合する。あるいは、強化繊維100が骨螺子1のネジ山5の螺旋方向に配置されるように、樹脂に混合する。樹脂は、熱硬化性樹脂及び熱可塑性樹脂の少なくとも1つを含む。例えば、樹脂は、エポキシ系、フェノール系、及び不飽和ポリエステル系等の樹脂から選択されればよい。 When injection molding a bone screw using the reinforcing fiber 100, a mixed composition of the reinforcing fiber 100 (for example, 1 mm carbon fiber) and a resin (for example, vinyl ester) is placed in the mold of the bone screw 1, and the bone It is ejected from the head side of the screw 1 in the insertion direction of the bone screw 1. In this case, when forming the mixed composition, the reinforcing fibers 100 are mixed with the resin so that the reinforcing fibers 100 are arranged in a predetermined direction. For example, the reinforcing fibers 100 are mixed with the resin so that the reinforcing fibers 100 are arranged in the axial direction of the bone screw 1. Alternatively, the reinforcing fibers 100 are mixed with the resin so that the reinforcing fibers 100 are arranged at a position extending at a predetermined angle with respect to the axial direction of the bone screw 1. Alternatively, the reinforcing fibers 100 are mixed into the resin so that they are arranged in the helical direction of the threads 5 of the bone screw 1. The resin includes at least one of a thermosetting resin and a thermoplastic resin. For example, the resin may be selected from epoxy resins, phenolic resins, unsaturated polyester resins, and the like.
 これらのように、所定の位置に強化繊維100が混合された混合組成物を骨螺子1の金型に射出することで、強化繊維100は、シャフト部2において、シャフト部2の軸方向に延伸する位置に配置されたり、強化繊維100は、ネジ山5において屈曲したり、ネジ山5の螺旋方向と同じ方向に延伸する位置に配置されたり、シャフト部2及びネジ山5の少なくとも1つにおいて、軸方向の周りを螺旋状に巻回する位置に配置されたりする。 As described above, by injecting a mixed composition in which the reinforcing fibers 100 are mixed into a predetermined position into the mold of the bone screw 1, the reinforcing fibers 100 are stretched in the axial direction of the shaft part 2 in the shaft part 2. The reinforcing fiber 100 may be bent at the thread 5 or may be arranged at a position extending in the same direction as the helical direction of the thread 5, or the reinforcing fiber 100 may be bent at the thread 5, or may be arranged at a position where it extends in the same direction as the helical direction of the thread 5. , and may be arranged in a position where it is wound spirally around the axial direction.
 成型された骨螺子1において、強化繊維100が所定の方向に適切に配置されることにより、骨螺子1の圧縮強度、引張強度、剪断強度、捩り強度、及び硬度の少なくとも1つを強化することができる。 In the molded bone screw 1, the reinforcing fibers 100 are appropriately arranged in a predetermined direction to strengthen at least one of compressive strength, tensile strength, shear strength, torsional strength, and hardness of the bone screw 1. Can be done.
 強化繊維100は、炭素繊維、アラミド繊維、ガラス繊維の少なくとも1つが好ましいが、これらに限定されない。 The reinforcing fiber 100 is preferably at least one of carbon fiber, aramid fiber, and glass fiber, but is not limited to these.
 図2は、強化繊維100と樹脂の混合組成物を骨螺子1の金型に射出成型した骨螺子1の断面図である。ネジ山5の角度は、60度以上80度以下である。 FIG. 2 is a cross-sectional view of a bone screw 1 in which a mixed composition of reinforcing fibers 100 and a resin is injection molded into a mold for the bone screw 1. The angle of the thread 5 is 60 degrees or more and 80 degrees or less.
 発明者は、鋭意研究を行った結果、強化繊維100と樹脂の混合組成物を骨螺子1の金型に射出し、骨螺子1のネジ山5を適切に成型するためのネジ山5の角度を見出した。金型におけるネジ山部の角度が小さ過ぎる場合、混合組成物がネジ山部まで十分に射出されず、ネジ山5が適切に成型されない。一方、金型におけるネジ山部の角度が大き過ぎる場合、骨螺子1の骨への固定強度が不十分となり、骨から容易に脱離してしまう。 As a result of extensive research, the inventor injected a mixed composition of reinforcing fibers 100 and resin into a mold for the bone screw 1, and determined the angle of the thread 5 for appropriately molding the thread 5 of the bone screw 1. I found out. If the angle of the threads in the mold is too small, the mixed composition will not be sufficiently injected to the threads, and the threads 5 will not be properly molded. On the other hand, if the angle of the threaded portion of the mold is too large, the fixing strength of the bone screw 1 to the bone will be insufficient and it will easily come off from the bone.
 図2(a)(b)は、ネジ山5の角度は、それぞれ120度と100度である。図2(a)(b)に示すように、混合組成物がネジ山部まで十分に射出されているが、ネジ山部の角度が大き過ぎ、骨から容易に脱離してしまう。 In FIGS. 2(a) and 2(b), the angles of the threads 5 are 120 degrees and 100 degrees, respectively. As shown in FIGS. 2(a) and 2(b), although the mixed composition is sufficiently injected to the threaded portion, the angle of the threaded portion is too large and easily detaches from the bone.
 図2(c)(d)は、ネジ山5の角度は、それぞれ80度と60度である。図2(c)(d)に示すように、混合組成物がネジ山部まで十分に射出されており、ネジ山部の角度が大き過ぎることなく、骨から容易に脱離しない。したがって、ネジ山5の角度は、60度以上80度以下であることが適切である。好ましくは、ネジ山5の角度は、60度以上75度以下である。さらに好ましくは、ネジ山5の角度は、65度以上70度以下である。 In FIGS. 2(c) and 2(d), the angles of the threads 5 are 80 degrees and 60 degrees, respectively. As shown in FIGS. 2(c) and 2(d), the mixed composition is sufficiently injected to the threaded portion, and the angle of the threaded portion is not too large and does not easily detach from the bone. Therefore, it is appropriate that the angle of the thread 5 is 60 degrees or more and 80 degrees or less. Preferably, the angle of the thread 5 is 60 degrees or more and 75 degrees or less. More preferably, the angle of the thread 5 is 65 degrees or more and 70 degrees or less.
 図3は、ネジ山5の角度が、骨螺子1の挿入方向に向かうほど、60度乃至80度の範囲内で大きくなることを示す図である。図3に示すように、ネジ山5の角度θ1~θ3が、骨螺子1の挿入方向に向かうほど、60度乃至80度の範囲内で大きくなる(θ1<θ2<θ3)。好ましくは、ネジ山5の角度は、骨螺子1の挿入方向に向かうほど、60度以上75度以下の範囲内で大きくなる。さらに好ましくは、ネジ山5の角度は、骨螺子1の挿入方向に向かうほど、65度以上70度以下の範囲内で大きくなる。なお、ネジ山5の角度は、骨螺子1の挿入方向に向かうほど、上記の範囲内で漸次大きくなってもよいし、断続的に大きくなってもよいし、ネジ山5の一部が骨螺子1の挿入方向に向かうほど、上記の範囲内で大きくなってもよい。また、ネジ山5の高さh1~h3は、骨螺子1の挿入方向に向かうほど、低くなってもよい。ネジ山5の高さh1~h3は、ネジ山5の角度に応じて変化してもよい。 FIG. 3 is a diagram showing that the angle of the thread 5 increases in the range of 60 degrees to 80 degrees as it goes toward the insertion direction of the bone screw 1. As shown in FIG. 3, the angles θ1 to θ3 of the screw threads 5 increase in the range of 60 degrees to 80 degrees as the direction of insertion of the bone screw 1 increases (θ1<θ2<θ3). Preferably, the angle of the thread 5 increases in the range of 60 degrees or more and 75 degrees or less as it goes toward the insertion direction of the bone screw 1. More preferably, the angle of the thread 5 increases in the range of 65 degrees or more and 70 degrees or less as it goes toward the insertion direction of the bone screw 1. The angle of the thread 5 may gradually increase within the above range or may increase intermittently as it goes in the insertion direction of the bone screw 1, or a part of the thread 5 may It may become larger within the above range as it goes in the insertion direction of the screw 1. Further, the heights h1 to h3 of the screw threads 5 may become lower toward the insertion direction of the bone screw 1. The heights h1 to h3 of the threads 5 may vary depending on the angle of the threads 5.
 図4(a)は、骨螺子1の頭部4を示す図である。図4(b)は、骨螺子1のB-Bの断面図である。図4(b)に示すように、頭部4は、挿入方向に頭凸部41を備え、頭凸部41は、シャフト部2のシャフト凹部21に嵌合する。また、頭部4とシャフト部2との接合部(頭凸部41)が、シャフト部2に比べ、圧縮強度、引張強度、剪断強度、捩り強度、及び硬度の少なくとも1つが高い。例えば、頭凸部41は、金属(例えば、チタン、ステンレス、鉄、ニッケル、コバルト、及び超硬合金等)、セラミック(例えば、ジルコニア)、サーメット、及び強化繊維100と異なる組成の強化繊維の少なくとも1つを含む。ここで、強化繊維100と異なる組成の強化繊維とは、強化繊維100の混合比率、長さ、形状、及び配置の少なくとも1つが異なれば、強化繊維100と同種の強化繊維を用いてもよい。また、強化繊維100と異なる組成の強化繊維とは、他の強化繊維が混合されれば、強化繊維100と同種の強化繊維を用いてもよい。 FIG. 4(a) is a diagram showing the head 4 of the bone screw 1. FIG. 4(b) is a sectional view of the bone screw 1 taken along line BB. As shown in FIG. 4(b), the head 4 includes a head protrusion 41 in the insertion direction, and the head protrusion 41 fits into the shaft recess 21 of the shaft portion 2. Furthermore, the joint between the head 4 and the shaft portion 2 (the convex head portion 41) has higher at least one of compressive strength, tensile strength, shear strength, torsional strength, and hardness than the shaft portion 2. For example, the head convex portion 41 is made of at least metal (e.g., titanium, stainless steel, iron, nickel, cobalt, cemented carbide, etc.), ceramic (e.g., zirconia), cermet, and reinforcing fibers having a composition different from that of the reinforcing fibers 100. Contains one. Here, the reinforcing fibers having a different composition from the reinforcing fibers 100 may be reinforcing fibers of the same type as the reinforcing fibers 100, as long as at least one of the mixing ratio, length, shape, and arrangement of the reinforcing fibers 100 is different. Furthermore, the reinforcing fibers having a different composition from the reinforcing fibers 100 may be reinforcing fibers of the same type as the reinforcing fibers 100 if other reinforcing fibers are mixed therein.
 なお、頭凸部41及びシャフト凹部21によらなくても、頭部4とシャフト部2との接合部が、シャフト部2に比べ、圧縮強度、引張強度、剪断強度、捩り強度、及び硬度の少なくとも1つが高ければよい。 Note that even without the head protrusion 41 and the shaft recess 21, the joint between the head 4 and the shaft portion 2 has higher compressive strength, tensile strength, shear strength, torsional strength, and hardness than the shaft portion 2. It is sufficient that at least one of them is high.
 例えば、図示しないが、シャフト部2は、抜去方向にシャフト凸部を備え、シャフト凸部は、頭部4の頭凹部に嵌合してもよい。つまり、図4では、頭部4に凸部を備え、シャフト部2に凹部を備えるが、逆に、シャフト部2に凸部を備え、頭部4に凹部を備えてもよい。また、図示しないが、金属(例えば、チタン、ステンレス、鉄、ニッケル、コバルト、及び超硬合金等)、セラミック(例えば、ジルコニア)、サーメット、及び強化繊維100と異なる組成の強化繊維の少なくとも1つを含む芯部を備え、芯部は、頭部4の頭凹部とシャフト部2のシャフト凹部とに嵌合してもよい。つまり、頭部4及びシャフト部2に凹部を備え、当該凹部が芯部によって接続される。また、これら以外にも、シャフト部2に比べ、圧縮強度、引張強度、剪断強度、捩り強度、及び硬度の少なくとも1つが高い部分が頭部4とシャフト部2との接合部に備えられればよい。この場合、接合部は、図4のように、異なる材料に基づく頭部4とシャフト部2との境界面が存在してもよいし、同じ部材(例えば、同じ強化繊維)であって、明確な境界面が存在しなくてもよい。例えば、同じ材料(例えば、同じ強化繊維)の混合比率、長さ、形状、及び配置の少なくとも1つが連続的に異なることで、明確な境界面が存在しないが、シャフト部2に比べ、圧縮強度、引張強度、剪断強度、捩り強度、及び硬度の少なくとも1つが高い部分が頭部4とシャフト部2との間に備えられればよい。 For example, although not shown, the shaft portion 2 may include a shaft protrusion in the removal direction, and the shaft protrusion may fit into a head recess of the head 4. That is, in FIG. 4, the head 4 is provided with a convex portion and the shaft portion 2 is provided with a concave portion, but conversely, the shaft portion 2 may be provided with a convex portion and the head 4 may be provided with a concave portion. Although not shown, at least one of metals (e.g., titanium, stainless steel, iron, nickel, cobalt, cemented carbide, etc.), ceramics (e.g., zirconia), cermet, and reinforcing fibers having a composition different from that of the reinforcing fibers 100 The core part may be fitted into a head recess of the head 4 and a shaft recess of the shaft part 2. That is, the head 4 and the shaft portion 2 are provided with recesses, and the recesses are connected by the core. In addition to these, a portion having at least one of compressive strength, tensile strength, shear strength, torsional strength, and hardness higher than that of the shaft portion 2 may be provided at the joint portion between the head portion 4 and the shaft portion 2. . In this case, the joint may be a boundary between the head 4 and the shaft 2 made of different materials, as shown in FIG. There does not have to be any boundary surface. For example, if at least one of the mixing ratio, length, shape, and arrangement of the same materials (e.g., the same reinforcing fibers) are continuously different, there is no clear boundary surface, but the compressive strength is higher than that of the shaft part 2. , a portion having high at least one of tensile strength, shear strength, torsional strength, and hardness may be provided between the head 4 and the shaft portion 2.
 これにより、荷重がかかる頭部4とシャフト部2との間の部分において、圧縮強度、引張強度、剪断強度、捩り強度、及び硬度の少なくとも1つを強化することができ、骨螺子1が破断や変形することを防ぐことができる。 As a result, at least one of compressive strength, tensile strength, shear strength, torsional strength, and hardness can be strengthened in the part between the head 4 and the shaft part 2 where the load is applied, and the bone screw 1 can be broken. and deformation can be prevented.
 図5は、骨螺子1の斜視図である。図6は、図5の骨螺子1の透視図である。図7は、図5の骨螺子1のC-Cの断面図である。 FIG. 5 is a perspective view of the bone screw 1. FIG. 6 is a perspective view of the bone screw 1 of FIG. 5. FIG. 7 is a sectional view taken along line CC of the bone screw 1 in FIG.
 図5~図7に示すように、頭部4は、挿入方向に頭凸部41を備え、頭凸部41は、シャフト部2のシャフト凹部21に嵌合する。 As shown in FIGS. 5 to 7, the head 4 includes a head protrusion 41 in the insertion direction, and the head protrusion 41 fits into the shaft recess 21 of the shaft portion 2.
 また、図6に示すように、頭凸部41は、軸方向に直行する断面が多角形である多角形部41-1を備える。多角形部41-1は、軸方向に直行する断面が略四角形であり、面取りが施されている。多角形部41―1は、略三角形乃至略六角形であることが好ましい。頭凸部41が軸方向に直行する断面で多角形であることで、骨螺子1の回転方向にトルクが生じた場合に、頭凸部41がシャフト凹部21から回転方向に滑ったり外れたりすることを防止することができる。 Further, as shown in FIG. 6, the head convex portion 41 includes a polygonal portion 41-1 whose cross section perpendicular to the axial direction is a polygon. The polygonal portion 41-1 has a substantially rectangular cross section perpendicular to the axial direction, and is chamfered. The polygonal portion 41-1 is preferably approximately triangular to approximately hexagonal. Since the head protrusion 41 has a polygonal cross-section perpendicular to the axial direction, when torque is generated in the rotational direction of the bone screw 1, the head protrusion 41 slides or comes off from the shaft recess 21 in the rotational direction. This can be prevented.
 図7に示すように、頭凸部41は、切欠部22を備える。切欠部22は、骨螺子1の回転方向の回転面を含んでもよいし、フランジ形状であってもよい。頭凸部41が切欠部22を備えることで、頭凸部41がシャフト凹部21から軸方向に滑ったり外れたりすることを防止することができる。また、図示しないが、頭凸部41は、ネジ山5と逆螺旋方向に位置するネジ山を備えてもよい。 As shown in FIG. 7, the head protrusion 41 includes a notch 22. The cutout portion 22 may include a rotation surface in the rotational direction of the bone screw 1, or may have a flange shape. By providing the head protrusion 41 with the notch 22, it is possible to prevent the head protrusion 41 from slipping or coming off from the shaft recess 21 in the axial direction. Further, although not shown, the head convex portion 41 may include a screw thread located in a reverse helical direction to the screw thread 5.
 同様に、シャフト凹部21は、軸方向に直行する断面が多角形である多角形部又はネジ山5と逆螺旋方向に位置するネジ山、及び切欠部の少なくとも1つを備えてもよい。 Similarly, the shaft recess 21 may include at least one of a polygonal section whose cross section perpendicular to the axial direction is a polygon, a thread located in a reverse helical direction with respect to the thread 5, and a notch.
 また、上記のように、シャフト部2の凸部が頭部4の凹部に嵌合する場合や、芯部が頭部4の頭凹部とシャフト部2のシャフト凹部とに嵌合する場合は、シャフト部2の凸部、頭部4の凹部、及び芯部が、軸方向に直行する断面が多角形である多角形部又はネジ山5と逆螺旋方向に位置するネジ山、及び切欠部の少なくとも1つを備えてもよい。 In addition, as described above, when the convex part of the shaft part 2 fits into the recessed part of the head part 4, or when the core part fits into the head recessed part of the head part 4 and the shaft recessed part of the shaft part 2, The convex part of the shaft part 2, the concave part of the head part 4, and the core part have a polygonal part whose cross section perpendicular to the axial direction is a polygon, or a thread located in a reverse spiral direction with respect to the thread 5, and a notch part. At least one may be provided.
 なお、芯部は、軸方向に延伸する位置及び軸方向の周りを螺旋状に巻回する位置の少なくとも1つの位置に配置される強化繊維を含んでもよい。 Note that the core portion may include reinforcing fibers arranged at at least one of a position extending in the axial direction and a position spirally wound around the axial direction.
 図6及び図7に示すように、骨螺子1は、軸方向で骨螺子1の内部を貫通可能な孔部20を備える。図6及び図7では、孔部20は、頭部4のリセス40から先端部3まで骨螺子1の内部を貫通している。 As shown in FIGS. 6 and 7, the bone screw 1 includes a hole 20 that can pass through the inside of the bone screw 1 in the axial direction. 6 and 7, the hole 20 passes through the interior of the bone screw 1 from the recess 40 of the head 4 to the distal end 3. In FIGS.
 孔部20は、金属(例えば、チタン、ステンレス、鉄、ニッケル、コバルト、及び超硬合金等)、セラミック(例えば、ジルコニア)、サーメット、及び強化繊維100と異なる組成の強化繊維の少なくとも1つを含む材料で囲まれている。ここで、強化繊維100と異なる組成の強化繊維とは、強化繊維100の混合比率、長さ、形状、及び配置の少なくとも1つが異なれば、強化繊維100と同種の強化繊維を用いてもよい。また、強化繊維100と異なる組成の強化繊維とは、他の強化繊維が混合されれば、強化繊維100と同種の強化繊維を用いてもよい。 The hole 20 is made of at least one of metal (e.g., titanium, stainless steel, iron, nickel, cobalt, cemented carbide, etc.), ceramic (e.g., zirconia), cermet, and reinforcing fiber having a composition different from that of the reinforcing fiber 100. Surrounded by containing materials. Here, the reinforcing fibers having a different composition from the reinforcing fibers 100 may be reinforcing fibers of the same type as the reinforcing fibers 100, as long as at least one of the mixing ratio, length, shape, and arrangement of the reinforcing fibers 100 is different. Furthermore, the reinforcing fibers having a different composition from the reinforcing fibers 100 may be reinforcing fibers of the same type as the reinforcing fibers 100 if other reinforcing fibers are mixed therein.
 金属(例えば、チタン、ステンレス、鉄、ニッケル、コバルト、及び超硬合金等)、セラミック(例えば、ジルコニア)、サーメット、及び強化繊維100と異なる組成の強化繊維を含む材料で囲まれた孔部20がCT画像等の医用画像において孔部20の周辺部より輝度が高く撮像される場合、孔部20が、医用画像における骨螺子1の位置や方向を把握するためのガイドとして機能する。 Hole 20 surrounded by a material including metal (e.g., titanium, stainless steel, iron, nickel, cobalt, and cemented carbide), ceramic (e.g., zirconia), cermet, and reinforcing fibers having a composition different from reinforcing fiber 100 When the image is captured in a medical image such as a CT image with higher brightness than the surrounding area of the hole 20, the hole 20 functions as a guide for understanding the position and direction of the bone screw 1 in the medical image.
 なお、孔部20の少なくとも一部が、金属(例えば、チタン、ステンレス、鉄、ニッケル、コバルト、及び超硬合金等)、セラミック(例えば、ジルコニア)、サーメット、及び強化繊維100と異なる組成の強化繊維の少なくとも1つを含む材料で囲まれていればよい。 Note that at least a portion of the hole 20 is made of metal (e.g., titanium, stainless steel, iron, nickel, cobalt, cemented carbide, etc.), ceramic (e.g., zirconia), cermet, or reinforced fiber having a composition different from that of the reinforcing fiber 100. It suffices if it is surrounded by a material containing at least one fiber.
 図8は、骨螺子1のネジ山5のタイプの例を示す図である。図8(a)の骨螺子1では、ネジ山5の挿入方向側のフランク角は、ネジ山5の抜去方向側のフランク角より大きい。図8(b)の骨螺子1では、シャフト部2が挿入方向に向かうほど細くなっており、ネジ山5の谷の径は挿入方向に向かうほど細くなって小さくなっている。一方、図8(b)の骨螺子1では、ネジ山5の外径は略一定である。図8(b)の骨螺子1では、ネジ山5の高さは、挿入方向に向かうほど、大きくなる。また、図8(b)の骨螺子1では、ネジ山5の頂の軸方向の長さは、挿入方向に向かうほど、小さくなる。 FIG. 8 is a diagram showing examples of the types of threads 5 of the bone screw 1. In the bone screw 1 shown in FIG. 8A, the flank angle of the thread 5 in the insertion direction is larger than the flank angle of the thread 5 in the removal direction. In the bone screw 1 shown in FIG. 8(b), the shaft portion 2 becomes thinner toward the insertion direction, and the diameter of the valley of the thread 5 becomes thinner and smaller toward the insertion direction. On the other hand, in the bone screw 1 shown in FIG. 8(b), the outer diameter of the thread 5 is substantially constant. In the bone screw 1 shown in FIG. 8(b), the height of the thread 5 increases toward the insertion direction. Further, in the bone screw 1 shown in FIG. 8(b), the length of the top of the screw thread 5 in the axial direction becomes smaller toward the insertion direction.
 このようなネジ山5の形状により、骨螺子1を確実に骨に固定することができ、容易に骨から抜去することができる。 Due to the shape of the screw thread 5, the bone screw 1 can be reliably fixed to the bone and can be easily removed from the bone.
 図9は、骨螺子1のネジ山5のタイプの他の例を示す図である。図9は、骨螺子1のネジ山5の断面図である。図9(a)の骨螺子1では、ネジ山5の挿入方向側のフランク角αは、ネジ山5の抜去方向側のフランク角βより大きい。図9(b)の骨螺子1では、ネジ山5(ネジ山5-1,5-2,5-3)の高さH1,H2,H3は、挿入方向に向かうほど大きくなる。また、図9(b)の骨螺子1では、ネジ山5(ネジ山5-1,5-2,5-3)の頂の軸方向の長さL1,L2,L3は、挿入方向に向かうほど、小さくなる。なお、ネジ山5の谷の径及びネジ山5の角度γは略一定である。図9(c)の骨螺子1では、シャフト部2が挿入方向に向かうほど細くなっており、ネジ山5(ネジ山5-4,5-5,5-6)の谷の径は挿入方向に向かうほど細くなって小さくなっている。一方、ネジ山5の外径及びネジ山5の角度γは略一定である。ネジ山5(ネジ山5-4,5-5,5-6)の高さH4,H5,H6は、挿入方向に向かうほど、大きくなる。また、図9(c)の骨螺子1では、ネジ山5(ネジ山5-4,5-5,5-6)の頂の軸方向の長さL4,L5,L6は、挿入方向に向かうほど小さくなる。 FIG. 9 is a diagram showing another example of the type of thread 5 of the bone screw 1. FIG. 9 is a cross-sectional view of the thread 5 of the bone screw 1. In the bone screw 1 shown in FIG. 9A, the flank angle α of the thread 5 in the insertion direction is larger than the flank angle β of the thread 5 in the removal direction. In the bone screw 1 shown in FIG. 9(b), the heights H1, H2, and H3 of the screw threads 5 (thread threads 5-1, 5-2, and 5-3) increase toward the insertion direction. In addition, in the bone screw 1 shown in FIG. 9(b), the axial lengths L1, L2, and L3 of the tops of the screw threads 5 (thread threads 5-1, 5-2, and 5-3) are in the insertion direction. The smaller it becomes. Note that the diameter of the valley of the thread 5 and the angle γ of the thread 5 are substantially constant. In the bone screw 1 shown in FIG. 9(c), the shaft portion 2 becomes thinner toward the insertion direction, and the diameter of the valley of the screw threads 5 (thread threads 5-4, 5-5, 5-6) is in the insertion direction. It becomes thinner and smaller as it goes towards the end. On the other hand, the outer diameter of the thread 5 and the angle γ of the thread 5 are substantially constant. The heights H4, H5, and H6 of the threads 5 (threads 5-4, 5-5, and 5-6) increase toward the insertion direction. In addition, in the bone screw 1 in FIG. 9(c), the axial lengths L4, L5, and L6 of the tops of the screw threads 5 (thread threads 5-4, 5-5, and 5-6) are in the insertion direction. The smaller it becomes.
 このようなネジ山5の形状により、骨螺子1を確実に骨に固定することができ、容易に骨から抜去することができる。 Due to the shape of the screw thread 5, the bone screw 1 can be reliably fixed to the bone and can be easily removed from the bone.
 図10は、ハウジング6に収納された骨螺子1が、ハウジング6内でナット(図示しない)により固定され、ロッド7により連結されたこと示す図である。 FIG. 10 is a diagram showing that the bone screw 1 housed in the housing 6 is fixed within the housing 6 by a nut (not shown) and connected by a rod 7.
 図10(a)に示すように、骨螺子1のネジ山5-7は、図8(b)のネジ山5と同様の形状である。図10(b)に示すように、骨螺子1のネジ山5のピッチは、挿入方向に向かうほど長くなる。 As shown in FIG. 10(a), the threads 5-7 of the bone screw 1 have the same shape as the threads 5 in FIG. 8(b). As shown in FIG. 10(b), the pitch of the threads 5 of the bone screw 1 becomes longer toward the insertion direction.
 このようなネジ山5の形状により、骨螺子1を確実に骨に固定することができ、容易に骨から抜去することができる。 Due to the shape of the screw thread 5, the bone screw 1 can be reliably fixed to the bone and can be easily removed from the bone.
 図11は、動物(豚)の骨に骨螺子1を螺入した状態で撮像したCT画像(医用画像)である。図11では、骨螺子1が、0重量%以上30重量%以下(0重量%,10重量%,15重量%,20重量%,25重量%,30重量%)のタンタルを、強化繊維を含む組成物に混合した混合物を含む。 FIG. 11 is a CT image (medical image) taken with the bone screw 1 screwed into the bone of an animal (pig). In FIG. 11, the bone screw 1 contains tantalum of 0 weight % or more and 30 weight % or less (0 weight %, 10 weight %, 15 weight %, 20 weight %, 25 weight %, 30 weight %) and reinforcing fibers. including mixtures mixed into compositions.
 図12は、図11のタンタルの含有率に応じて撮像したCT画像(医用画像)における骨螺子1のアーチファクトを評価した表である。 FIG. 12 is a table evaluating artifacts of the bone screw 1 in CT images (medical images) taken according to the tantalum content shown in FIG. 11.
 図11及び図12に示すように、混合物におけるタンタルの含有率が高くなるほどCT画像(医用画像)における骨螺子1のアーチファクトは強くなる。混合物におけるタンタルの含有率が25重量%及び30重量%の場合、アーチファクトの評価はAであり、許容される。他の金属(チタン、ステンレス、鉄、ニッケル、コバルト、及び超硬合金等)であっても、同様の結果となると予測される。したがって、骨螺子1(シャフト部2、先端部3、頭部4、及びネジ山5の少なくとも1つ)は、0重量%超30重量%以下(好ましくは、10重量%以上20重量%以下、さらに好ましくは、10重量%以上15重量%以下)の金属(タンタル、チタン、ステンレス、鉄、ニッケル、コバルト、及び超硬合金等)を、強化繊維100を含む組成物に混合した混合物を含む。 As shown in FIGS. 11 and 12, the higher the content of tantalum in the mixture, the stronger the artifact of the bone screw 1 in the CT image (medical image). When the content of tantalum in the mixture is 25% and 30% by weight, the artifact rating is A - , which is acceptable. Similar results are expected for other metals (titanium, stainless steel, iron, nickel, cobalt, cemented carbide, etc.). Therefore, the bone screw 1 (at least one of the shaft portion 2, the tip portion 3, the head 4, and the screw thread 5) contains more than 0% by weight and less than 30% by weight (preferably 10% by weight and less than 20% by weight), More preferably, the reinforcing fiber 100 contains a mixture of a metal (tantalum, titanium, stainless steel, iron, nickel, cobalt, cemented carbide, etc.) containing 10% by weight or more and 15% by weight or less, such as tantalum, titanium, stainless steel, iron, nickel, cobalt, and cemented carbide.
 アーチファクトを軽減しつつ、骨螺子1(シャフト部2、先端部3、頭部4、及びネジ山5の少なくとも1つ)が医用画像において周辺部より輝度が高く撮像される場合、骨螺子1(シャフト部2、先端部3、頭部4、及びネジ山5の少なくとも1つ)が、医用画像における骨螺子1の位置や方向を把握するためのガイドとして機能する。 When the bone screw 1 (at least one of the shaft portion 2, the tip portion 3, the head 4, and the screw thread 5) is imaged with higher brightness than the surrounding area in a medical image while reducing artifacts, the bone screw 1 ( At least one of the shaft portion 2, the tip portion 3, the head portion 4, and the screw thread 5) functions as a guide for grasping the position and direction of the bone screw 1 in a medical image.
 また、先端部3は、強化繊維100に比べ、医用画像において高輝度で撮像される材料を含んでもよい。例えば、先端部3は、金属(例えば、タンタル、チタン、ステンレス、鉄、ニッケル、コバルト、及び超硬合金等)、セラミック(例えば、ジルコニア)、サーメット、及び強化繊維100と異なる組成の強化繊維の少なくとも1つを含む。このような先端部3が、CT画像等の医用画像において先端部3の周辺部より輝度が高く撮像される場合、先端部3が、医用画像における骨螺子1の位置や方向を把握するためのガイドとして機能する。 Additionally, the tip portion 3 may include a material that is imaged with higher brightness in medical images than the reinforcing fiber 100. For example, the tip portion 3 may be made of metal (e.g., tantalum, titanium, stainless steel, iron, nickel, cobalt, cemented carbide, etc.), ceramic (e.g., zirconia), cermet, or reinforcing fiber having a composition different from that of the reinforcing fiber 100. Contains at least one. When such a distal end 3 is imaged with higher brightness than the surrounding area of the distal end 3 in a medical image such as a CT image, the distal end 3 is used for grasping the position and direction of the bone screw 1 in the medical image. Act as a guide.
 以上、本発明にかかる実施形態について説明したが、本発明はこれらに限定されるものではなく、請求項に記載された範囲内において変更・変形することが可能である。 Although the embodiments according to the present invention have been described above, the present invention is not limited to these, and can be modified and modified within the scope of the claims.
 本発明は、十分な強度を備える骨螺子として有用である。 The present invention is useful as a bone screw with sufficient strength.
1…骨螺子
2…シャフト部
3…先端部
4…頭部
5…ネジ山
6…ハウジング
7…ロッド
20…孔部
21…シャフト凹部
22…切欠部
40…リセス
41…頭凸部
41―1…多角形部
100…強化繊維
 
1... Bone screw 2... Shaft part 3... Tip part 4... Head 5... Screw thread 6... Housing 7... Rod 20... Hole 21... Shaft recess 22... Notch 40... Recess 41... Head protrusion 41-1... Polygonal part 100...reinforced fiber

Claims (22)

  1.  強化繊維を含む骨螺子であって、
     シャフト部と、
     前記シャフト部の挿入方向の端部に位置する先端部と、
     前記シャフト部の抜去方向の端部に位置する頭部と、
     前記シャフト部の外周部において前記シャフト部の軸方向に螺旋状に位置するネジ山とを備え、
     前記強化繊維は、前記シャフト部において、前記シャフト部の軸方向に延伸する位置に配置されることを特徴とする骨螺子。
    A bone screw containing reinforcing fibers,
    a shaft part;
    a tip portion located at the end of the shaft portion in the insertion direction;
    a head located at the end of the shaft portion in the removal direction;
    a screw thread located spirally in the axial direction of the shaft portion on the outer circumference of the shaft portion,
    The bone screw characterized in that the reinforcing fibers are arranged in the shaft portion at a position extending in the axial direction of the shaft portion.
  2.  前記頭部と前記シャフト部との間に、前記シャフト部に比べ、圧縮強度、引張強度、剪断強度、捩り強度、及び硬度の少なくとも1つが高い部分が存在することを特徴とする請求項1に記載の骨螺子。 According to claim 1, there is a portion between the head portion and the shaft portion that has higher compressive strength, tensile strength, shear strength, torsional strength, and hardness than the shaft portion. Bone screw described.
  3.  前記頭部は、
     前記挿入方向に頭凸部を備え、
     前記頭凸部は、前記シャフト部のシャフト凹部に嵌合することを特徴とする請求項1又は請求項2に記載の骨螺子。
    The head is
    a head convex portion in the insertion direction;
    The bone screw according to claim 1 or 2, wherein the head convex portion fits into a shaft recess of the shaft portion.
  4.  前記頭凸部及び前記シャフト凹部の少なくとも1つは、前記軸方向に直行する断面が多角形である多角形部又は前記ネジ山と逆螺旋方向に位置するネジ山、及び切欠部の少なくとも1つを備えることを特徴とする請求項3に記載の骨螺子。 At least one of the head convex portion and the shaft recess is a polygonal portion whose cross section perpendicular to the axial direction is a polygon, a thread located in a reverse helical direction to the thread, and at least one of a notch. The bone screw according to claim 3, comprising:
  5.  前記頭凸部は、金属、セラミック、サーメット、及び前記強化繊維と異なる組成の強化繊維の少なくとも1つを含むことを特徴とする請求項3に記載の骨螺子。 The bone screw according to claim 3, wherein the head protrusion includes at least one of metal, ceramic, cermet, and reinforcing fibers having a composition different from the reinforcing fibers.
  6.  前記シャフト部は、
     前記抜去方向にシャフト凸部を備え、
     前記シャフト凸部は、前記頭部の頭凹部に嵌合することを特徴とする請求項1又は請求項2に記載の骨螺子。
    The shaft portion is
    A shaft convex portion is provided in the removal direction,
    The bone screw according to claim 1 or 2, wherein the shaft protrusion fits into a head recess of the head.
  7.  前記シャフト凸部及び前記頭凹部の少なくとも1つは、前記軸方向に直行する断面が多角形である多角形部、前記ネジ山と逆螺旋方向に位置するネジ山、及び切欠部の少なくとも1つを備えることを特徴とする請求項6に記載の骨螺子。 At least one of the shaft convex portion and the head recess is at least one of a polygonal portion whose cross section perpendicular to the axial direction is a polygon, a screw thread located in a reverse helical direction with respect to the screw thread, and a notch. The bone screw according to claim 6, comprising:
  8.  金属、セラミック、サーメット、及び前記強化繊維と異なる組成の強化繊維の少なくとも1つを含む芯部を備え、
     前記芯部は、前記頭部の頭凹部と前記シャフト部のシャフト凹部とに嵌合することを特徴とする請求項1又は請求項2に記載の骨螺子。
    comprising a core containing at least one of metal, ceramic, cermet, and reinforcing fibers having a composition different from the reinforcing fibers,
    The bone screw according to claim 1 or 2, wherein the core part fits into a head recess of the head and a shaft recess of the shaft part.
  9.  前記芯部は、前記軸方向に延伸する位置及び前記軸方向の周りを螺旋状に巻回する位置の少なくとも1つの位置に配置される前記強化繊維を含むことを特徴とする請求項8に記載の骨螺子。 9. The core includes the reinforcing fibers arranged in at least one of a position extending in the axial direction and a position spirally wound around the axial direction. bone screw.
  10.  前記軸方向で前記骨螺子の内部を貫通可能な孔部を備え、
     前記孔部は、金属、セラミック、サーメット、及び前記強化繊維と異なる組成の強化繊維の少なくとも1つを含む材料で囲まれていることを特徴とする請求項1又は請求項2に記載の骨螺子。
    comprising a hole that can penetrate the inside of the bone screw in the axial direction,
    The bone screw according to claim 1 or 2, wherein the hole is surrounded by a material containing at least one of metal, ceramic, cermet, and reinforcing fibers having a composition different from the reinforcing fibers. .
  11.  前記先端部は、前記強化繊維に比べ、医用画像において高輝度で撮像される材料を含むことを特徴とする請求項1又は請求項2に記載の骨螺子。 The bone screw according to claim 1 or 2, wherein the tip portion includes a material that is imaged with higher brightness in medical images than the reinforcing fibers.
  12.  前記強化繊維は、前記シャフト部及び前記ネジ山の少なくとも1つにおいて、前記軸方向の周りを螺旋状に巻回する位置に配置されるように延伸することを特徴とする請求項1又は請求項2に記載の骨螺子。 2. The reinforcing fiber is stretched in at least one of the shaft portion and the screw thread so as to be wound in a helical manner around the axial direction. 2. The bone screw according to 2.
  13.  前記強化繊維は、前記ネジ山において、前記ネジ山の螺旋方向と同じ方向に延伸する位置に配置されることを特徴とする請求項1又は請求項2に記載の骨螺子。 The bone screw according to claim 1 or 2, wherein the reinforcing fibers are arranged in the screw thread at a position extending in the same direction as the helical direction of the screw thread.
  14.  前記強化繊維は、前記ネジ山において屈曲することを特徴とする請求項1又は請求項2に記載の骨螺子。 The bone screw according to claim 1 or 2, wherein the reinforcing fibers are bent at the threads.
  15.  前記強化繊維は、炭素繊維、アラミド繊維、ガラス繊維の少なくとも1つであることを特徴とする請求項1又は請求項2に記載の骨螺子。 The bone screw according to claim 1 or 2, wherein the reinforcing fiber is at least one of carbon fiber, aramid fiber, and glass fiber.
  16.  前記シャフト部、前記先端部、前記頭部、及び前記ネジ山の少なくとも1つは、0重量%超30重量%以下の金属を、前記強化繊維を含む組成物に混合した混合物を含むことを特徴とする請求項1又は請求項2に記載の骨螺子。 At least one of the shaft portion, the tip portion, the head portion, and the screw thread includes a mixture in which more than 0% by weight and 30% by weight or less of metal is mixed into the composition containing the reinforcing fibers. The bone screw according to claim 1 or claim 2.
  17.  前記ネジ山の角度は、60度以上80度以下であることを特徴とする請求項1又は請求項2に記載の骨螺子。 The bone screw according to claim 1 or 2, wherein the angle of the thread is 60 degrees or more and 80 degrees or less.
  18.  前記ネジ山の角度は、前記挿入方向に向かうほど、60度乃至80度の範囲内で大きくなることを特徴とする請求項1又は請求項2に記載の骨螺子。 The bone screw according to claim 1 or 2, wherein the angle of the thread increases in the range of 60 degrees to 80 degrees as it goes toward the insertion direction.
  19.  前記ネジ山の前記挿入方向側のフランク角は、前記ネジ山の前記抜去方向側のフランク角より大きいことを特徴とする請求項1又は請求項2に記載の骨螺子。 The bone screw according to claim 1 or 2, wherein the flank angle of the thread on the insertion direction side is larger than the flank angle of the thread on the extraction direction side.
  20.  前記ネジ山の高さは、前記挿入方向に向かうほど大きくなることを特徴とする請求項1又は請求項2に記載の骨螺子。 The bone screw according to claim 1 or 2, wherein the height of the thread increases toward the insertion direction.
  21.  前記ネジ山の頂の前記軸方向の長さは、前記挿入方向に向かうほど小さくなることを特徴とする請求項1又は請求項2に記載の骨螺子。 The bone screw according to claim 1 or 2, wherein the length of the crest of the thread in the axial direction becomes smaller toward the insertion direction.
  22.  前記ネジ山のピッチは、前記挿入方向に向かうほど長くなることを特徴とする請求項1又は請求項2に記載の骨螺子。 The bone screw according to claim 1 or 2, wherein the pitch of the thread becomes longer toward the insertion direction.
PCT/JP2023/025979 2022-07-29 2023-07-14 Bone screw WO2024024533A1 (en)

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JP2022-121944 2022-07-29

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0450001A (en) * 1990-06-20 1992-02-19 Koya Kensetsu Kogyo:Yugen Slip prevention device of automotive wheel
JP2012518080A (en) * 2009-02-16 2012-08-09 バイエル・インターナショナル・ソシエテ・アノニム Coupling means, manufacturing method thereof, and material joining
JP2014037893A (en) * 2013-11-29 2014-02-27 Nitto Seiko Co Ltd Screw component
JP5443398B2 (en) * 2010-01-08 2014-03-19 ビーダーマン・テクノロジーズ・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング・ウント・コンパニー・コマンディートゲゼルシャフト Bone screw
US20170181785A1 (en) * 2015-12-23 2017-06-29 Carbofix In Orthopedics Llc Multi-layer composite material bone screw
JP2020533046A (en) * 2017-09-07 2020-11-19 オッシオ リミテッド Threaded fiber reinforced biocomposite implant
JP2021011926A (en) * 2019-07-08 2021-02-04 中島特殊鋼株式会社 Bolt and nut

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0450001A (en) * 1990-06-20 1992-02-19 Koya Kensetsu Kogyo:Yugen Slip prevention device of automotive wheel
JP2012518080A (en) * 2009-02-16 2012-08-09 バイエル・インターナショナル・ソシエテ・アノニム Coupling means, manufacturing method thereof, and material joining
JP5443398B2 (en) * 2010-01-08 2014-03-19 ビーダーマン・テクノロジーズ・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング・ウント・コンパニー・コマンディートゲゼルシャフト Bone screw
JP2014037893A (en) * 2013-11-29 2014-02-27 Nitto Seiko Co Ltd Screw component
US20170181785A1 (en) * 2015-12-23 2017-06-29 Carbofix In Orthopedics Llc Multi-layer composite material bone screw
JP2020533046A (en) * 2017-09-07 2020-11-19 オッシオ リミテッド Threaded fiber reinforced biocomposite implant
JP2021011926A (en) * 2019-07-08 2021-02-04 中島特殊鋼株式会社 Bolt and nut

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